Sr. Clinical Data Manager
The Senior Clinical Data Manager is an individual contributor performing complex data management tasks independently. The Senior Clinical Data Manager plays a key role on multiple moderate to complex studies. In addition, the Senior Clinical Data Manager manages external vendors on assigned studies.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
- Refer to the Key Responsibilities section
- Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, Cross- functional Data Review Plan, with input from cross-functional study team
- Plans and oversees execution of User Acceptance Testing.
- Defines Electronic Data Transfer Specifications
- Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
- Reviews clinical study protocols and provides input
- Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
- Prepares and delivers presentations at internal and external meetings
- Oversees activities of a CDM team on multiple studies, including internal staff and vendors
- Evaluates and mitigates risks to timelines and quality
- Provides input regarding project resource requirements
- Responsible for all aspects of the CDM study deliverables
- May mentor other clinical data management staff
- Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS
In addition to the attributes of a Clinical Data Manager:
- Subject Matter Expert in EDC-related tools and processes
- Demonstrates well-developed instincts and problem-solving skills in all areas of data management
- Understands cross-functional team roles within Clinical Development
- Able to provide some leadership on a cross-functional team and work effectively in a matrix environment
Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.